Wednesday

Aug 31, 2016 at 1:02 PMAug 31, 2016 at 4:34 PM

Butler Hospital researchers share credit in major scientific report

PROVIDENCE — In what could prove a landmark development in the fight against Alzheimer’s disease, scientists on Wednesday reported that a drug now undergoing clinical trials has been able to reduce brain deposits of amyloid plaque, an underlying cause of the disease that today afflicts 5.2 million Americans — including 23,000 Rhode Islanders — who are 65 or older.

The drug, Aducanumab, manufactured by Biogen of Cambridge, Mass., also demonstrated ability to slow the cognitive decline characteristic of the disease as it inevitably progresses to death, according to the report, to be published in the Sept. 1 edition of Nature, the most frequently cited scientific publication in the world.

Co-authored by Dr. Stephen P. Salloway, who as director of Butler Hospital’s Memory and Aging program has led one major branch of the Aducanumab clinical trials, the paper is announced with placement filling more than half the cover of Nature — a sign of the importance assigned to it by the publication’s editors and peer reviewers, who were not involved in the trials.

“This is the best news in my 25 years of conducting Alzheimer’s disease research,” Salloway told The Journal. “These results bring new hope to patients and families most affected and move us one step closer to meeting the U.S. National Plan goal of treatment breakthroughs by 2025. This report represents a major milestone in the war on Alzheimer’s.”

The paper, “The antibody aducanumab reduces amyloid-beta plaques in Alzheimer’s disease,” was authored by 28 scientists, most from Biogen, with others besides Salloway from Neurimmune, a Swiss firm, and the University of Zurich’s Institute for Regenerative Medicine. The unusually high number of authors reflects the wide scope of research behind the clinical trials, which, it is hoped, will help speed the drug to market.

“Confirmation that an anti-amyloid beta treatment slows down cognitive decline would be a game-changer for how we understand, treat and prevent Alzheimer’s disease,” wrote Dr. Eric Reiman in an accompanying article in Nature. Reiman, executive director and chief scientific officer of the Banner Alzheimer’s Institute in Phoenix and a psychiatry professor at the University of Arizona, was not an author.

The research described in Nature were double-blind, placebo-controlled studies involving 165 patients, including Neil Corkery, a 75-year-old former educator and state legislator whose story was told in the Sunday Journal, along with a report and video about Salloway and the Butler program.

“After 54 weeks of treatment,” Nature concluded, “amyloid beta was significantly reduced in the brains of patients who received aducanumab and higher doses were associated with greater amyloid reduction; there was little change in the brains of those who received the placebo. Of the 40 patients that discontinued treatment, 20 did so due to adverse effects, which included dose-dependent amyloid related imaging abnormalities.”

Translation: a handful of patients developed fluid in the brain, which seemed to correlate with the dose. Other side effects, including headaches and urinary tract infections, were comparatively mild. No patients were hospitalized for fluid accumulation, and there were no drug-related deaths, according to the paper.

With the fluid finding in mind, doses have been adjusted for the next stage of the trial, Phase III, which researchers hope will lead to FDA approval for Aducanumab. No drug currently on the market does more than treat symptoms of Alzheimer’s, and without a breakthrough, the cost of Alzheimer’s care is projected to increase from $236 billion in 2016 to more than $1 trillion in 2050, according to the Alzheimer's Association.

Salloway said that Butler is now enrolling patients with early Alzheimer’s in the Phase III confirmatory study.

"I am excited to be part of a dedicated, talented and caring team of men and women working in partnership with so many courageous study volunteers to make a difference in the fight against Alzheimer's disease," Salloway told The Journal. “A guiding tenet in Judaism is Tikkun Olam, or ‘repairing the world.’ The work we are doing is very satisfying because it is clearly in the spirit of Tikkun Olam.”

Salloway is also professor of neurology and psychiatry at Alpert Medical School of Brown University, and a staff neurologist at Rhode Island Hospital, where some of the Butler research is conducted.

Butler Hospital's Memory and Aging Program can be reached by calling (401) 455-6402, or visiting the program site.

gwmiller@providencejournal.com

(401) 277-7380

On Twitter: @GWayneMiller

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